Application of in Vivo Splitting Technique in Adult Liver Transplantation

Application of in Vivo Splitting Technique of Brain-dead Donor Liver in Adult Liver Transplantation

The feasibility of split liver transplantation (SLT) remains controversial. This study aimed to evaluate the outcomes of SLT in adult recipients and to identify specific areas of improvements. A retrospective analysis was conducted on adults who underwent full size SLT between January 2021 and December 2023. The short-term outcomes of these patients who underwent SLT were compared with those of patients who underwent whole liver transplantation (WLT) during the same period.

Study Overview

• Status: Active, not recruiting
• Conditions: Liver Transplantation
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315000
      • Ningbo Medical Centre Lihuili Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult recipients who underwent SLT or WLT

Description

Inclusion Criteria:

• For the donor graft:

  1. age of 18-60 years;
  2. BMI of 19-28 kg/m2;
  3. hemodynamic stability or use of a single vasoactive drug with a small dosage (norepinephrine ≤ 0.1 μg/kg/min or dopamine ≤ 5 μg/kg/min);
  4. liver steatosis ≤ 10%;
  5. liver functional indicators (ALT, AST, total bilirubin quantification) ≤ 3 times the normal value;
  6. blood sodium ≤ 160 mmol/L;

For the SLT recipients

1. Patients who had registered in the China Organ Transplant Response Systems.
2. Initial liver transplantation.
3. Graft-to-Recipient Weight Ratio (GRWR) ≥ 1%.

Exclusion Criteria:

• For the donor graft

  1. uncontrollable infection
  2. significant vascular and biliary variation.

For the recipients

1. Severe portal hypertension.
2. Significant vascular variation.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SLT group; Adult recipients who underwent split liver transplantation	Other: No intervention; No intervention
WLT group; Adult recipients who underwent whole liver transplantation	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	the overall survival of liver transplant recipient during study period	2021.01.01-2025.12.31

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Postoperative complications of liver transplant recipient during study period	2021.01.01-2025.12.31

Collaborators and Investigators

• Sponsor: Ningbo Medical Center Lihuili Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Surgical complications; Short-term Outcomes; Split liver transplantation; Whole liver transplantation; Morbidity and Mortality
• Other Study ID Numbers: CT2025-LHL-OBS1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No